Auditor - Technical File Reviewer

EPM Scientific; Remote; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

An established notified body in Germany is looking for an Auditor to join their remote team. In this role, you will review technical files related to active medical devices and conduct audits to ensure compliance with international standards. Candidates should have a degree in a relevant field, fluency in German, and experience in technical file reviews. Strong communication and project management skills are also essential for this position.

Qualifikationen

• Familiar with active medical device products is essential.
• Degree in Biology, Chemistry, Pharmacy, Medicine, Agriculture, Veterinary Medicine.
• Experience in active medical device technical file reviews and testing/inspection.

Aufgaben

• Conduct reviews of technical files related to medical devices.
• Perform conformity assessment to international/regional standards.
• Ensure technical files comply with standards and assess product safety.

Kenntnisse

Familiarity with active medical device products

Fluent in German language (written and spoken)

Communication skills

Project management skills

Ausbildung

Bachelor's, Master's or Doctoral degree in relevant fields

Jobbeschreibung

Our client is an established notified body with international operations. They test, audit, inspect and advise medical technology clients.

They are looking to add an Auditor to the team in Germany conducted technical file reviews and audits of active medical devices.

The certification company have offices in Germany and internationally, however this is a remote position.

Duties

• As Auditor, you will participate in reviews of technical files related to domestic and international laws and regulations related to active medical device. This will be across med tech and diagnostics products
• You will conduct conformity assessment to international / regional standards (ISO13485 etc.) and technical document evaluations
• The aim of the position is to ensure technical files are compiled in accordance with standards and whether there are any problems with product safety, documents / files

Qualifications

• You will need familiarity with active medical device products
• Have either a Bachelor's, Master's or Doctoral degree (Biology, Chemistry, Pharmacy, Medicine, Agriculture, Veterinary Medicine, etc.)
• Experience in active medical device technical file reviews and testing / inspection
• Fluent in German language (written and spoken)
• Communication and project management skills

Desired Skills and Experience

audit, technical files, active medical devices, German, notified body